Warning letter
Fresenius Kabi AG: warning letter of Sep 14, 2023
FDA warning letter 657085 · Division of Biological Products Operations I
Key facts
| Reference number | 657085 |
|---|---|
| Company | Fresenius Kabi AG |
| Subject | CGMP Deviations |
| Issue date | Sep 14, 2023 |
| Posted date | Sep 29, 2023 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 211.58, 211.192, 211.67(a), 211.110(c), 211.113(b), 211.160(b) |
| Inspection city | Maricao |
| Inspection ZIP | 00606 |
| Inspection start date | Sep 12, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: